An expedited assessment of cancer risk associated with exposure to N-nitrosodimethylamine (NDMA) through the recently recalled valsartan products has concluded that there is no markedly increased overall short-term risk of cancer.
However, for single cancer outcomes, there was a slight non-significant increased risk of colorectal and uterine cancer.
In July, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) withdrew a number of valsartan products from the market after it emerged some of the products manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals were potentially contaminated with N-nitrosodimethylamine (NDMA), which has carcinogenic properties.
Amid emerging public health concerns, researchers investigated the association between use of the potentially contaminated valsartan products and risk of cancer among 5,150 patients from Danish Health Registries who were aged 40 years and older, with no previous cancer, who used valsartan between 1 January 2012 and 30 June 2018.
They found exposure to potentially NDMA-contaminated valsartan showed no association with cancer compared with exposure to valsartan products that were not contaminated.
Presenting the findings in the BMJ, the authors said studies with longer follow-up are needed to assess long-term cancer risk.